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Not yet recruiting NCT07301567

Pilot Study of Negative Pressure Neck Therapy (NPNT)

No phase Interventional Obstructive Apnea Sleep Apnea Syndrome, Obstructive Sleep Disorder (Disorder)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Negative Pressure Neck Therapy (NPNT).
Who it may be relevant to
Registry conditions: Obstructive Apnea, Sleep Apnea Syndrome, Obstructive, Sleep Disorder (Disorder). Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Proof-of-concept Pilot Study to Determine the Safety and Effectiveness of the Negative Pressure Neck Therapy (NPNT) in Healthy Participants.

Overview

Obstructive sleep apnea (OSA) is a serious, chronic sleep-related breathing disease in which the upper airway repeatedly collapses during sleep, leading to intermittent oxygen deprivation. This pilot study will evaluate the Safety and Efficacy of Negative Pressure Neck Therapy (NPNT) in up to 10 healthy participants. Participants will undergo 2 separate home sleep apnea tests (HSAT) approximately 1 week apart and will be randomly assigned to wear the NPNT device at either night 1 or night 2 of HSAT. Participation will include 5 on-site visits and 1 phone call over approximately 1 month.

Detailed description

Purpose: To determine the safety and efficacy of the Negative Pressure Neck Therapy (NPNT) in Healthy Participants.

Negative pressure neck therapy (NPNT) uses a self-contained, non-invasive, external device to apply a gentle, outward pulling effect around the neck's surface.

Hypothesis: Given the exploratory nature and small sample size no formal hypothesis testing will be conducted

Objectives:

Primary Objective:

1\. To determine if NPNT can effectively reduce the number of apnea-hypopnea index (AHI) events (sleep disorder breathing events) in healthy participants.

Secondary Objectives:

1. To determine the tolerability of the NPNT 2. To determine the duration of time required for acclimating to the device 3. To determine the NPNT parameters (optimal device fit) based on participant characteristics. 4. To collect feedback from participants regarding the device use, comfort, fit, function, usability, etc.

Safety and Efficacy Objectives:

1. To evaluate the safety and effectiveness of NPNT 2. To assess potential side effects of NPNT.

Interventions

  • Device Negative Pressure Neck Therapy (NPNT)
    Negative pressure neck therapy (NPNT) is a self-contained, non-invasive, soft, flexible, external neck collar

Primary outcome measures

  • Comparison of the number of sleep-disordered breathing events between intervention and control nights as assessed by Home Sleep Apnea Test (HSAT). [Time frame: 1 night]
Secondary outcome measures (6)
  • Tolerability of NPNT device based on duration of time (hours) worn during NPNT intervention night as assessed by Participant Report and Home Sleep Apnea Test (HSAT) [Time frame: 1 night]
  • Participant Characteristics will be assessed compared to NPNT device fit/shape based on participant response on the Device Evaluation Questionnaire using Likert scores. [Time frame: 1 night]
  • Participant reported device tolerability will be assessed using the Device Evaluation Questionnaire Likert scale responses. [Time frame: 1 night]
  • Participant Reported Feedback on shape and fit of NPNT device as assessed by the Device Evaluation Questionnaire using a Likert Scale (≥3 on Likert scale) [Time frame: 1 night]
  • Participant Feedback on NPNT device comfort, usability and function based on the Device Evaluation Questionnaire using a Likert scale [Time frame: 1 night]
  • Participant Feedback on NPNT device based on qualitative data (open comments) from the Device Evaluation Questionnaire after the NPNT device intervention night. [Time frame: 1 night]

Eligibility criteria

Inclusion criteria

  • Body mass index ≤42 kg/m2
  • Able to speak, read, and write English

Exclusion criteria

  • Known sleep disorder such as Obstructive Sleep Apnea (OSA), narcolepsy, restless leg syndrome, idiopathic hypersomnolence or chronic insomnia
  • No previous surgery, injury, or radiation to the neck
  • Excessive hair or beard in the area of the neck, and/or unwillingness to shave that area for the duration of this study
  • Inflammatory skin condition, such as acne or eczema in the neck area
  • Known silicone allergy
  • Night shift work because of irregular sleep-wake cycles
  • Excessive alcohol intake, defined as that leading to interference with work, home life, or the ability to optimally perform normal everyday duties and tasks
  • Use of illicit drugs currently or within the past 5 years
  • Serious pulmonary disease
  • Use of home oxygen or oxygen saturation <94%
  • Cancer that has been in remission for less than one year
  • Previous surgery for peripheral arterial disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Device feasibility

Study locations

Canada · 2 centers
  • Centre for Lung Health — Vancouver
  • Leon Judah Blackmore Centre for Sleep Disorders — Vancouver

Identifiers

NCT: NCT07301567 · H25-02563

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗